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RSS FeedPosted by Michael Wonder on 24 Oct 2017
Medical device development tools: helping to speed medical device evaluation and approval
24 October 2017 - The FDA relies on sound science in its decision-making, which provides medical device innovators with a ...
Posted by Michael Wonder on 24 Oct 2017
Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to advance medical device innovation and help patients gain faster access to beneficial technologies
24 October 2017 - Enabling patients and providers to have efficient access to new and innovative medical products that meet ...
Posted by Michael Wonder on 24 Oct 2017
FDA approves Soliris (eculizumab) for the treatment of patients with generalised myasthenia gravis
23 October 2017 - First FDA approved treatment in more than 60 years for patients with generalised myasthenia gravis, a ...
Posted by Michael Wonder on 24 Oct 2017
US FDA approves new easy-to-use, once-weekly Bydureon BCise injectable medicine for patients with type 2 diabetes
23 October 2017 - New formulation of once-weekly exenatide in an improved device provides significant HbA1c reduction with added benefit ...
Posted by Michael Wonder on 24 Oct 2017
United Therapeutics announces FDA approval of third generation nebuliser for the Tyvaso inhalation system
23 October 2017 - United Therapeutics today announced approval by the U.S. FDA of a new inhalation device, called the ...
Posted by Michael Wonder on 23 Oct 2017
GSK wins U.S. shingles vaccine approval, UK nod for gene therapy
23 October 2017 - GlaxoSmithKline has won U.S. approval for a new and improved shingles vaccine, the second of three ...
Posted by Michael Wonder on 23 Oct 2017
Novartis combination adjuvant therapy Tafinlar and Mekinist receives FDA breakthrough therapy designation for stage III BRAF V600 mutation-positive melanoma patients
23 October 2017 - First targeted combination therapy to demonstrate a clinical benefit in patients with a BRAF V600E/K mutation in ...
Posted by Michael Wonder on 22 Oct 2017
Will the FDA add suffixes to approved biologics' names?
20 October 2017 - Back in January, the US FDA finalised guidance on how biosimilars and their biologic reference products' ...
Posted by Michael Wonder on 21 Oct 2017
Janssen receives two U.S. FDA approvals for Simponi Aria (golimumab) for the treatment of adults with active psoriatic arthritis or active ankylosing spondylitis
20 October 2017 - Simponi Aria is the only fully-human anti-TNF-alpha infused therapy now approved for psoriatic arthritis, ankylosing spondylitis ...
Posted by Michael Wonder on 21 Oct 2017
Shingrix approved in the US for prevention of shingles in adults aged 50 and over
20 October 2017 - Pooled clinical trial results showed > 90 percent efficacy across all age groups. ...
Posted by Michael Wonder on 21 Oct 2017
FDA releases flurry of new, revised drug-specific guidance documents
19 October 2017 - The US FDA on Thursday released new draft guidances for 32 drugs, including for those companies ...
Posted by Michael Wonder on 20 Oct 2017
Antares Pharma receives complete response letter from the FDA for Xyosted
20 October 2017 - Antares Pharma announced that today it has received a complete response letter from the U.S. FDA ...
Posted by Michael Wonder on 19 Oct 2017
Breast cancer: BRCA study sent to Canada because U.S. thinks women can't handle genetic test results
19 October 2017 - Hundreds of spit samples have been traveling through the mail across the U.S.-Canadian border. Why? The ...
Posted by Michael Wonder on 19 Oct 2017
Teva announces submission of biologics license application for fremanezumab to the U.S. FDA
17 October 2017 - Key milestone reached for Teva to advance global fremanezumab program for the preventive treatment of migraine. ...
Posted by Michael Wonder on 19 Oct 2017
FDA approves another amazing and costly cancer-killing gene therapy
18 October 2017 - In 2010, Josh Feldman was on his honeymoon -- a globe-spanning trip that at one point ...